Novo Nordisk's Once-Weekly Subcutaneous Anti-Obesity Drug AM833 Granted Clinical Trial Approval in China

On December 16, the Center for Drug Evaluation (CDE) announced that Novo Nordisk’s AM833 (NNC0174-0833 injection) had received default approval for clinical trials, with planned development for weight management in patients with obesity or overweight.

AM833 is a novel once-weekly subcutaneous injectable islet amyloid polypeptide (IAPP) analog developed by Novo Nordisk. IAPP, also known as amylin, is a peptide hormone released by the pancreas during meals, concurrently with insulin. Amylin aids the digestive process by helping to control the rate of gastric emptying. Its primary function is to slow down food digestion and the release of glucose into the bloodstream. AM833 can reduce body weight by decreasing food intake.

A 26-week Phase II clinical study enrolled a total of 706 subjects with obesity or overweight and at least one obesity-related comorbidity, who received AM833 (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg, 4.5 mg), liraglutide (3.0 mg), or placebo. The results demonstrated that the study met its primary endpoint: at Week 26, patients in the AM833 4.5 mg dose group achieved a 10.8% reduction in body weight from baseline, compared to a 3.0% reduction in the placebo group. AM833 exhibited a favorable safety and tolerability profile.

Novo Nordisk has conducted clinical studies of AM833 in multiple countries.

Source: PharmaCube NextPharma

Obesity is a chronic disease requiring long-term treatment and is associated with numerous serious health consequences and reduced life expectancy. Obesity also leads to many complications, including type 2 diabetes, heart disease, obstructive sleep apnea, chronic kidney disease, non-alcoholic fatty liver disease, and cancer.